Janumet XR Dosage/Direction for Use

General: The dosage of antihyperglycemic therapy with JANUMET XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.
Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose.
JANUMET XR should be given once daily with a meal preferably in the evening. Additionally, administration of JANUMET XR with food enhances plasma concentrations of metformin. To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing. There have been reports of incompletely dissolved JANUMET XR tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
Dosing Recommendations: The starting dose of JANUMET XR should be based on the patient’s current regimen.
JANUMET XR tablets are available in the following strengths: 50 mg sitagliptin/500 mg extended-release metformin hydrochloride, 50 mg sitagliptin/1000 mg extended-release metformin hydrochloride, 100 mg sitagliptin/1000 mg extended-release metformin hydrochloride.
For patients taking two tablets of the 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablet or the 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet, the two tablets should be taken together once daily. The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily.
As initial therapy: For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. Patients with inadequate glycemic control on this dose can be titrated gradually to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily metformin dose of 2000 mg.
For patients inadequately controlled on metformin monotherapy: For patients inadequately controlled on metformin alone, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and the previously prescribed dose of metformin.
For patients inadequately controlled on sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the recommended starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. The metformin dose can be titrated as needed to achieve glycemic control. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to JANUMET XR (see Contraindications).
For patients switching from coadministration of sitagliptin and metformin: For patients switching from coadministration of sitagliptin and metformin, JANUMET XR may be initiated at the previously prescribed dose of sitagliptin and metformin.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea: The usual starting dose of JANUMET XR should provide 100 mg total daily dose of sitagliptin. In determining the starting dose of the metformin component, the patient’s level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia (see Precautions).
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPAR γ agonist: The usual starting dose of JANUMET XR should provide 100 mg total daily dose of sitagliptin and a dose of metformin similar to the dose already being taken.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The usual starting dose of JANUMET XR should provide 100 mg total daily dose of sitagliptin and a dose of metformin similar to the dose already being taken. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia (see Precautions).
No studies have been performed specifically examining the safety and efficacy of JANUMET XR in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Renal impairment: An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with eGFR <60 mL/min/1.73m².
If no adequate strength of JANUMET XR is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 7.)

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